FDA NEWS RELEASE

FDA: Possible Fracture Risk with High Dose, Long-term Use of Proton Pump InhibitorsLabeling changes will include new safety information

The U.S. Food and Drug Administration today warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.

Proton pump inhibitors, available by prescription and over-the-counter (OTC), work by reducing the amount of acid in the stomach. Prescription proton pump inhibitors include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex). Prescription proton pump inhibitors are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

OTC versions, used for the treatment of frequent heartburn, include omeprazole (Prilosec OTC, Zegerid OTC) and lansoprazole (Prevacid 24HR).

“Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses,” said Joyce Korvick, M.D., deputy director for safety in FDA’s Division of Gastroenterology Products. “Because these products are used by a great number of people, it’s important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.”

FDA’s warning and decision to revise the labeling of proton pump inhibitors are based on the Agency’s review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist and spine in patients using proton pump inhibitors. Both the Warnings and Precautions section of the prescription labeling and the Drug Facts label on OTC proton pump inhibitors will address these findings.

Health care professionals and consumers should weigh the known benefits against the potential risks of proton pump inhibitors when determining if these medications are appropriate for treatment. Consumers also should talk with their health care professional about any concerns.

Any side effects or other product problems with proton pump inhibitors should be reported to FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.